Morph AccessPro Steerable Introducer MAP690

GUDID 00866749000257

BIOCARDIA, INC.

Vascular guide-catheter, single-use

• Primary Device ID: 00866749000257
• NIH Device Record Key: eb3d16f5-b887-466c-a3b7-54f35add4547
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Morph AccessPro Steerable Introducer
• Version Model Number: MAP690
• Catalog Number: MAP690
• Company DUNS: 122370146
• Company Name: BIOCARDIA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com
• Phone: 6502260120
• Email: info@biocardia.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866749000257 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090999

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00866749000257]

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[00866749000257]

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[00866749000257]

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Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-23
• Device Publish Date: 2016-10-10

On-Brand Devices [Morph AccessPro Steerable Introducer]

• 00866749000257: MAP690
• 00866749000240: MAP645